# Garetosmab PDUFA Event: Fibrodysplasia ossificans progressiva

Canonical URL: https://biopharmsignal.com/pdufa-calendar/REGN/garetosmab-fibrodysplasia-ossificans-progressiva

Ticker: REGN

Company: Regeneron Pharmaceuticals

Event date: 2026-08-31

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: BLA

FDA decision expected. Regeneron disclosed an August 2026 FDA target action month. The structured Event Date uses August 31 as the month-end representation o...

## Event Timeline

### August 2026 — FDA decision expected

Regeneron disclosed an August 2026 FDA target action month. The structured Event Date uses August 31 as the month-end representation of this month-level disclosure.

[Regeneron — BLA acceptance and August 2026 target action month](https://newsroom.regeneron.com/news-releases/news-release-details/garetosmab-biologics-license-application-accepted-fda-priority/)

### February 19, 2026 — FDA accepted the BLA with Priority Review

FDA accepted the garetosmab BLA for adults with FOP under Priority Review and set the target action date in August 2026.

[Regeneron — FDA Priority Review for garetosmab](https://newsroom.regeneron.com/news-releases/news-release-details/garetosmab-biologics-license-application-accepted-fda-priority/)

### September 17, 2025 — OPTIMA met its primary endpoint

Both garetosmab doses reduced the number of new heterotopic ossification lesions by at least 90% versus placebo at Week 56, with a greater than 99% reduction in total new lesion volume.

[Regeneron — Positive Phase 3 OPTIMA results](https://investor.regeneron.com/news-releases/news-release-details/regeneron-announces-positive-phase-3-trial-adults-ultra-rare)

### November 21, 2022 — Phase 3 OPTIMA study started

The pivotal OPTIMA study began enrolling adults with fibrodysplasia ossificans progressiva to compare two garetosmab dose regimens with placebo.

[ClinicalTrials.gov — OPTIMA study record (NCT05394116)](https://clinicaltrials.gov/study/NCT05394116)

## Regulatory Designations

- Priority Review FDA: [Regeneron — FDA acceptance and Priority Review](https://newsroom.regeneron.com/news-releases/news-release-details/garetosmab-biologics-license-application-accepted-fda-priority/)

- Fast Track FDA: [Regeneron — Garetosmab regulatory designations](https://newsroom.regeneron.com/news-releases/news-release-details/garetosmab-biologics-license-application-accepted-fda-priority/)

- Orphan Drug FDA: [Regeneron — Garetosmab regulatory designations](https://newsroom.regeneron.com/news-releases/news-release-details/garetosmab-biologics-license-application-accepted-fda-priority/)

## Related Pages

- REGN PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/REGN.md

- REGN company profile: https://biopharmsignal.com/company/REGN.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

- 2026-08-19 — Regeneron Announces Investor Conference Presentations: https://biopharmsignal.com/news/REGN/regeneron-announces-investor-conference-presentations-4174227d.md

- 2026-08-19 — Pasatru™ (garetosmab-grts) First and Only FDA-approved Treatment Demonstrating Reduction in New Heterotopic Ossification (HO) Lesions and Clinician-Assessed Flare-ups in a Placebo-controlled Trial in Adults with Fibrodysplasia Ossificans Progressiva (FOP): https://biopharmsignal.com/news/REGN/pasatru-garetosmab-grts-first-and-only-fda-approved-treatment-demonstrating-redu-533dc642.md

- 2026-07-31 — Regeneron Awards $150,000 to Winners of the 2026 Regeneron Prize for Creative Innovation: https://biopharmsignal.com/news/REGN/regeneron-awards-150-000-to-winners-of-the-2026-regeneron-prize-for-creative-inn-b562f013.md

- 2026-07-30 — Regeneron Reports Second Quarter 2026 Financial and Operating Results: https://biopharmsignal.com/news/REGN/regeneron-reports-second-quarter-2026-financial-and-operating-results-39145cc1.md

- 2026-06-25 — Regeneron to Report Second Quarter 2026 Financial and Operating Results and Host Conference Call and Webcast: https://biopharmsignal.com/news/REGN/regeneron-to-report-second-quarter-2026-financial-and-operating-results-and-host-c2e371f6.md